ISO 11615 Investigational Medicinal Product

The identifier for the Investigational Medicinal Product shall be always specified as text. (11.3.2.2.2)

The combined pharmaceutical dose form shall be specified, where applicable, as described in 9.2.2.2.3 . (11.3.2.2.3)

The product code (identifier) for the Investigational Medicinal Product as designated by the sponsor can be specified in text. Either this code or the regulator product code (see 1 1.3.2.2.5 ) shall be specified. (11.3.2.2.4)

The product code (identifier) for the Investigational Medicinal Product as designated by the Medicines Regulatory Agency can be specified in text. Either this code or the sponsor product code (see 11.3. 2.2.4 ) shall be specified. (11.3.2.2.5)

If the Investigational Medicinal Product refers to a specific paediatric formulation, this can be specified using a controlled vocabulary. A term and a term identifier shall be used. (11.3.2.2.6)

The status of the clinical trial has to be specified. See ISO / TS 20443 for more information and examples. (11.3.2.2.7)

See 9.2.2.2.7 . (11.3.2.2.8)

11.3.2.6

The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)

The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)

The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)

The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)

This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)

This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)

This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)

11.4.2.2

The registration number (identifier) for a clinical trial in a region shall be specified. (11.4.2.2.2)

The code for a particular investigation (trial) as assigned in a jurisdiction for a clinical trial shall be specified in text. (11.4.2.2.3)

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.2.4)

The number assigned to the clinical trial protocol shall be specified. (11.4.2.2.5)

The date when the clinical trial authorisation was granted by a Medicines Regulatory Agency in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.6)

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol in a jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.2.7)

11.4.2.3

The registration number (identifier) for a clinical trial as assigned by the Regulatory Medicines Authority locally shall be specified in text. (11.4.2.3.2)

The “code” for an Investigational Medicinal Product as assigned locally for a clinical trial of a set of clinical trials shall be specified in text. (11.4.2.3.3)

The jurisdiction(s) in which the clinical trial authorisation was granted shall be described using ISO 3166 - 1 alpha-2 code elements. (11.4.2.3.4)

The date when the clinical trial authorisation was granted locally by a Regulatory Medicines Authority shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.5)

The date when the clinical trial is anticipated to be completed in accordance with the authorised clinical trial protocol shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (11.4.2.3.6)

9.3.2.5

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

11.4.2.4

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.3.2.4

This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)

The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)

This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)

This is the date when the SME status was granted. (9.3.2.4.4)

9.9.2.3

The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)

The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)

The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)

The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)

9.9.2.6

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

9.9.2.5

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

9.9.2.2

The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)

The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)

The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)

If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)

The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)

If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)

9.9.2.6

The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)

Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)

9.9.2.5

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

9.9.2.4

The text of the undesirable effect shall be given. (9.9.2.4.2)

The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)

The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)

The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)

9.9.2.5

The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)

The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)

The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)

The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)

The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)

Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)

11.3.2.5

This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)

The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)

This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)

This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)

This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)

9.9.2.7

The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)

This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)

The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)

The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)

The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)

The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)

11.3.2.8

The full and complete Investigational Medicinal Product name as assigned by the sponsor can be specified as text. Unlike the authorised Medicinal Product name, this information is not mandatory for Investigational Medicinal Products, but either this attribute or the product code attribute below shall be valued. (11.3.2.8.1)

The Investigational Medicinal Product may, in its initial development, be described by an informal “code” rather than by name; this shall be specified here, where applicable. For all the other name part attributes, the information is as described previously in 9.2.2.8 . (11.3.2.8.2)

The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)

The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)

The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)

The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)

The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)

The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)

The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)

The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)

The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)

The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)

The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)

The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)

A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)

9.2.2.9

The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)

The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)

The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)

11.2.7

This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)

A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)

9.6.2.8

The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)

The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)

This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)

9.5.2.2

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.5.2.3

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

9.3.2.5

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.6.2.3

The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)

The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)

The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)

The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)

9.6.2.4

The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)

The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)

9.6.2.12

The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)

This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)

The quantity of the device present in the pack shall be specified. (9.6.2.12.4)

This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)

A unique device identifier needs to be specified. (9.6.2.12.6)

This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)

Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)

Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)

The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)

11.12

Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)

Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)

9.6.2.13

The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)

This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)

This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)

11.11

The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)

The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)

9.5.2.2

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.5.2.3

The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)

The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)

The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)

The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)

9.3.2.5

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)

The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)

The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)

The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)

9.6.2.22

The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)

The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)

11.13

Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)

Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)

Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)

Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)

Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)

Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)

Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)

Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)

Where applicable, the imprint can be specified as text. (9.6.2.21.10)

Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)

Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)

9.6.2.11

This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)

The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)

Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)

9.6.2.20

This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)

This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)

The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)

11.2.9

The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)

This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)

9.5.2.2

The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)

The name of the organisation shall be provided in text. (9.4.2.2.3)

The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)

The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)

These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)

9.4.2.4

The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)

The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)

The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)

The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)

9.4.2.3

This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)